- For immediate release:
Today, the US Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently in the US market must be removed, or risk enforcement. The products include the JUUL device and four types of JUULpods: Virginia tobacco-flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol-flavored pods at nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with questions about products in their inventory.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarettes and electronic nicotine delivery system products currently marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, MD. “products from the companies that make up most of the US market. We recognize that these make up a significant proportion of the products available, and many have played a disproportionate role in the increase in youth armament.”
These MDOs apply only to the commercial distribution, import and retail sale of these products, and do not restrict individual consumer possession or use – the FDA can and will not enforce individual consumer possession or use of JUUL products or other tobacco products.
After reviewing the company’s pre-market applications for tobacco products (PMTA), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing the products would be appropriate to protect public health. In particular, some of the company’s study findings have raised concerns due to insufficient and conflicting data – including on genotoxicity and potentially harmful chemicals leaking from the company’s proprietary e-liquid pods – which have not been adequately treated and prevented the FDA from completing a full toxicological risk assessment. of the products mentioned in the company’s applications.
To date, the FDA has not received clinical information indicating an immediate danger associated with the use of the JUUL device or JUULpods. However, the MDOs issued today reflect the FDA’s decision that there is insufficient evidence to assess the potential toxicological risk of using JUUL products. There is also no way to know potential harms by using other authorized or unauthorized third party e-liquid pods with the JUUL device or using JUUL pods with a non-JUUL device. The FDA recommends against modifying or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health or product issues to the FDA through the Safety Reporting Portal and consult a physician as needed.
“The FDA’s mission is to ensure that tobacco products sold in this country meet the standard set by law, but the responsibility for demonstrating that a product meets these standards ultimately falls on the company’s shoulders,” said Michele Mital, acting director of the FDA Center. for tobacco products. “As with all manufacturers, JUUL had the opportunity to present evidence that the marketing of their products meets these standards. However, the company did not provide this evidence and left us with important questions instead. Without the data needed to determine relevant health risks, the FDA issues these marketing rejection orders. ”
Any products that are subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action.
In addition to ensuring that JUUL complies with this order, as with unauthorized products in general, the FDA intends to ensure compliance with distributors and resellers. Specifically, the FDA notes that all new tobacco products on the market without the statutory pre-market authorization are marketed illegally and are subject to enforcement.
As the FDA has previously stated, unauthorized electronic nicotine delivery system (ENDS) products that no application awaits, including those with an MDO, are among our highest enforcement priorities. Therefore, the FDA encourages retailers to discuss products in their inventory with their suppliers, including the current status of a particular tobacco product’s marketing application or marketing authorization. Manufacturers will be the best source of this information, and retailers should rely on manufacturers directly to inform decisions about which products to continue selling.
There are many resources to help smokers who want to quit. Quitting all tobacco products is the best possible way to good health. Some current JUUL users who do not want access to JUUL products after this action, or current smokers who want to get rid of cigarettes and cigars, may decide to switch to other ENDS products that have been reviewed and authorized by the FDA based on their potential to benefit adult smokers.
To date, the FDA has authorized 23 ENDS products. Under the PMTA route, applicants must, among other things, show the agency that allowing the marketing of the new tobacco product will be appropriate to protect public health.
The FDA continues to work on completing the review of the remaining applications for suspected products submitted by September 9, 2020.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.